SUPPLY CHAIN ARTICLES
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“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles
In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
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Defining The RNA Therapeutics Industry In 2023
Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.
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Assessing Quality Of mRNA Vaccines: Key Considerations
To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.
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Multidisciplinary mRNA: What Can We Learn From Other CGTs?
Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.
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Beyond The Gold Standard(s): Modernizing Oligonucleotide Synthesis
A few weeks ago, I had the chance to sit down with OPT Congress speaker Phil Baran, Richard Lerner Chair Professor, Department of Chemistry, Scripps Research. Baran was slated to (and did) present a keynote on the innovations shaping the next generation of oligo synthesis. Here, I share the biggest takeaways I had from our conversation, touching on how he sees the science of oligo chemistry and manufacturing advancing in the near and far future.
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Addressing Challenges In Serialization For Complex Therapeutics
The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
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CRISPR's potential depends on more than biology. Learn how advances in delivery, safety, manufacturing, and regulation are enabling clinical translation at scale.
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The story of how Moderna brought one of the first mRNA vaccines to the market has all the makings of a legend we will pass down through generations. However, unlike the legends of King Arthur or The Fountain of Youth, we can celebrate that Moderna’s legendary journey was — and still is — real. Not only did the mRNA vaccines help return life to normal, but they also kickstarted the mRNA therapeutic renaissance we’re happily experiencing today.
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We aim to highlight that commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.
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Explore a solution for biopharmaceutical companies concerned about the risks an increase in campaign volume can pose to their production timeline.
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Early integration of standardized, GMP-aligned cryopreservation improves consistency, documentation, and scalability in advanced therapy programs as they progress toward regulatory submissions.
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Uncover how how switching from LAL to rFC can enhance sustainability, improve testing reliability, and strengthen supply-chain resilience in endotoxin testing.